Regulatory Affairs specialist

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Morris Plains, New Jersey

Post: Fri, 31 Mar 2023 06:32:58 GMT

Expires: Fri, 28 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

This position will be working with multiple business units to develop, update, and improve regulatory affair processes.

Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.

Identify opportunity for regulatory affair processes and drive changes to completion.

Requirements:

Have working knowledge in EU MDR

Have working knowledge in Regulatory Change Assessment in

Have working knowledge in US and EU medical device submissions.

Have experience supporting internal and external inspections.

Work cross-functionally and in a matrixed environment.